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Siebel CRM Siebel Clinical Trial Management System Guide
Siebel Innovation Pack 2015, Rev. A
E52416-01
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A  B  C  D  E  F  G  I  J  L  M  N  O  P  R  S  T  U  V  W  X 

A

account assessment templates, creating, 6.5
accounts
assessing, 6.25
associating clinical protocols with, 4.8
associating clinical regions with, 4.10
associating sites with, 4.13
associating with clinical projects, 10.8
associating with contracts, 6.8
associating with sites, 6.9
creating for clinical trials, 4.11
maintaining, 6.6
action items, viewing universal inbox notifications for, 9.13
activities
associating with sites, 6.10
creating for clinical projects, 10.9
creating for document tracking, 6.19
defining for subject visits, 5.2.5
integrating data for subject visits with data for, 15.4, 16.7
activity completion, about integrating data for, 15.6, 16.12
activity plans, creating for sites, 6.16
activity templates
applying to sites, 6.17
creating for clinical projects, 10.4
address types, adding for sites, 6.14
administrative setup tasks, for Siebel Clinical, 3.9
applet properties, in Siebel Clinical, B.4
Assigned To fields, about adding users to MVG for, 14.8
assignment objects, predefined, 3.11.1
audit trail
using for changes to clinical trip reports, 9.18
using for changes to subject status, 5.22
using for reviews and approvals of clinical trip reports, 9.17
automated notification messages, for clinical trip reports, 9.10
automated validation messages, for clinical trip reports, 9.10

B

batch mode, administering subject visits in, 5.7
budgeting applications, importing plan data from, 12.5
business components, user properties for in Siebel Clinical, B.2
business services, user properties for in Siebel Clinical, B.3

C

case report forms
about exporting data for, 12.8
managing tracking activities for, 6.20
tracking, 6.21, 9.9
tracking for partial source data verification during site visits, 7.8
viewing for partial source data verification, 7.7
ClearTrial Clinical Trial Management System Connector
about, A.1
about logging for, A.1.2
configuring, A.3
configuring a proxy server for, A.4.1
configuring security for, A.4
sample configuration files for, A.2
supported integration points for, A.1.1
ClearTrial integration
activating workflows for, 12.3.2
completing prerequisites for, 12.3.1
configuring date and time format for, 12.3.4
configuring protocol integration fields for, 12.4
configuring Web services for, 12.3.3
process of setting up, 12.3
ClearTrial Track, importing data from Siebel Clinical to, A.5
clinical data capture and query management system integration
activating workflows for, 15.2.1
configuring Web services for, 15.2.3
overview of, 15.1
process of setting up, 15.2
setting up LS Clinical Integration workflow monitor agent for, 15.2.2
clinical data management system integration
about customizing Web services for, 16.2
activating workflows for, 16.3.2
configuring Java Message Service parameters for, 16.3.9
configuring JVM Subsystem for, 16.3.8
configuring Siebel Tools for, 16.3.1
configuring Web services for, 16.3.4
creating directory structure on Siebel Server for, 16.3.5
creating JNDI properties file for, 16.3.7
creating Oracle WebLogic full client JAR for, 16.3.6
overview of, 16.1
process of setting up, 16.3
setting up LS Clinical Integration workflow monitor agent for, 16.3.3
clinical operations integration
about customizing Web services for, 12.2
configuring system preferences for, 12.3.5
overview of, 12.1
clinical payments
about setting up and making for subject activities, 8.1
generating Oracle BI Publisher reports for, 8.16
scenario for, 8.2
clinical payments integration
about customizing Web services for, 17.2
activating workflows for, 17.3.2
configuring inbound Web services for, 17.3.3
configuring Java Message Service parameters for, 17.3.4
configuring Siebel Tools for, 17.3.1
overview of, 17.1
process of setting up, 17.3
clinical programs, creating, 4.4
clinical projects
about managing, 10.1
associating people and accounts with, 10.8
creating, 10.7
creating activities and tasks for, 10.9
creating activity templates for, 10.4
managing risk for, 10.11
monitoring costs for, 10.10
process of managing, 10.3
scenario for managing, 10.2
setting up employee profiles for, 10.5
clinical protocol site templates, creating, 6.4
clinical protocols
associating with accounts, 4.8
creating and revising versions for, 4.7
generating payment records for sites associated with, 8.11
integrating with Oracle clinical studies
setting up, 4.5
setting up partial source data verification for, 7.2
viewing enabled for synchronization, 16.9
viewing status accruals for clinical subjects of, 5.19
viewing training information for, 11.12
clinical regions
associating with accounts, 4.10
generating payment records for sites associated with, 8.11
setting up, 4.9
setting up partial source data verification for, 7.3
viewing status accruals for clinical subjects of, 5.18
viewing training information for, 11.13
clinical subjects
about exporting data for, 12.7
about integrating data for, 16.11
applying protocol amendments to, 5.15
applying revised subject visit templates to, 5.15.2
creating records for, 5.5
enrolling, 5.10
monitoring status accruals for by visit type, 5.21
randomizing, 5.11
recalculating requiring source data verification, 7.9
rescheduling, 5.6
rescreening, 5.9
scheduling, 5.5.1
screening, 5.8
setting up partial source data verification for, 7.6
terminating clinical trials early for, 5.14
tracking status accruals for, 9.12
viewing status accruals for, 5.17, 5.18, 5.19
clinical templates, about exporting data for, 14.6
clinical training
about managing, 11.1
setting up training topics for, 11.2
clinical trials
about setting up, 4.1
creating accounts and contacts for, 4.11
creating sites for, 4.12
performing risk assessments for, 4.14
process of managing, 4.3
scenario for, 4.2
terminating early for clinical subjects, 5.14
clinical trip report templates
applying, 9.5
creating, 9.4
clinical trip reports
about administering and using, 9.1
about customizing Web services for mobile integration of, 14.2
about exporting and importing data for, 14.12
approving, 9.15
automated validation and notification messages for, 9.10
completing, 9.6
completing questionnaires for, 9.7
creating questions for using Siebel SmartScript, 9.3
deleting, 9.19
deleting unanswered questions form questionnaires of, 9.8
overview of mobile integration for, 14.1
process of setting up mobile integration for, 14.4
scenario for managing, 9.2
setting up mobile integration for, 3.7
tracking completion status for, 9.11
using audit trail for changes to, 9.18
using audit trail for reviews and approvals of, 9.17
viewing, 9.14
viewing geographical location details for, 9.16
viewing geographical location details for site visits in, 13.6
viewing universal inbox notifications for action items of, 9.13
workflows for mobile integration of, 14.3
completed training
designating for contacts, 11.11
designating for training topics, 11.10
completion status, tracking for clinical trip reports, 9.11
contact assessment templates, creating, 6.5
contact assignments, in Siebel Clinical, 3.11.2
Contact Denormalization mode, in Siebel Life Sciences, 3.11.3
contacts
about exporting data for, 14.9
about managing for clinical trials, 6.1
assessing, 6.25
creating for clinical trials, 4.11
designating completed training for, 11.11
maintaining, 6.6
managing for sites, 6.13
process of managing for clinical trials, 6.3
scenario for managing for clinical trials, 6.2
contracts
associating accounts with, 6.8
associating with sites, 6.7
correspondence activities, creating for sites, 6.22
criteria, adding to training plans, 11.4

D

date format, configuring for ClearTrial integration, 12.3.4
document tracking
creating activities for, 6.19
generating Oracle BI Publisher reports for, 6.26
documents
associating with sites, 6.11
tracking and adding at sites, 6.18
domain value maps, populating, 16.3.10
DTE data maps
exporting from server database to XML file, 3.12.1.1
importing to local client from XML file, 3.12.1.2

E

employee profiles, setting up for clinical projects, 10.5

F

field properties, in Siebel Clinical, B.5
final payments, generating for sites, 8.14

G

geographical location details
about exporting for sites, 13.5
viewing for clinical trip reports, 9.16
viewing for site visits in clinical trip reports, 13.6

I

inbound Web Services, configuring for clinical payments integration, 17.3.3
investigators, about integrating data for, 16.6

J

Java Message Service parameters
configuring for clinical data management system integration, 16.3.9
configuring for clinical payments integration, 17.3.4
JDM Subsystem, configuring for clinical data management system integration, 16.3.8
JNDI properties file, creating for clinical data management system integration, 16.3.7

L

lists of values, about exporting data for, 14.5
LS Clinical Get Site Snapshot Service workflow, 14.3.2
LS Clinical Integration workflow monitor agent
setting up for clinical data capture and query management system integration, 15.2.2
setting up for clinical data management system integration, 16.3.3
LS Clinical Protocol Site Get Sites workflow, 14.3.1

M

mobile integration
activating workflows for, 14.4.2
completing integration prerequisites for, 14.4.1
configuring Web services for, 14.4.3
customizing Web services for, 14.2
overview of, 14.1
process of setting up for clinical trip reports, 14.4
setting up for clinical trip reports, 3.7
workflows for, 14.3
mobile Web clients, setting up for position rollup, 3.12
My Team’s filter, about, 3.10

N

notes, adding to sites, 6.23

O

Oracle BI Publisher reports
generating for clinical payments, 8.16
generating for document tracking, 6.26
generating for site enrollment status, 5.23
generating for site visits, 9.20
Oracle clinical studies, integrating with Siebel clinical protocols, 16.5
Oracle Clinical, integration entities for, 16.4
Oracle InForm integration, configuring protocol integration fields for, 15.3
Oracle WebLogic full client JAR, creating for clinical data management system integration, 16.3.6

P

partial source data verification
about, 7.1
about for protocol amendments, 7.10
setting up for clinical protocols, 7.2
setting up for clinical regions, 7.3
setting up for clinical subjects, 7.6
setting up for sites, 7.5
setting up for subject visit templates, 7.4
tracking case report forms for during site visits, 7.8
viewing case report forms for, 7.7
payees, splitting payment activities between multiple, 8.5
payment activities
creating for sites, 8.9
generating payment records for unplanned, 8.12
reversing splits for, 8.7
splitting between multiple payees, 8.5
payment amounts, adjusting and generating payment records for sites, 8.13
payment exceptions, setting up for sites, 8.4
payment records
creating for sites, 8.10
generating for sites, 8.13
generating for sites associated with clinical protocols and clinical regions, 8.11
generating for unplanned payment activities, 8.12
reverting, 8.15
payment requests
sending to third-party payments application, 17.4
viewing feedback for, 17.6
withdrawing, 17.5
payment splits, copying details for, 8.6
people, associating with clinical projects, 10.8
plan data, importing from budgeting applications, 12.5
position rollup, setting up for mobile Web clients, 3.12
position types, setting up for billing, 10.6
processed payments, verifying, 17.7
Projects screen, about views in, 10.12
protocol amendments
about partial source data verification for, 7.10
applying to sites and clinical subjects, 5.15
rules for applying, 5.15.3
protocol integration fields
configuring for ClearTrial integration, 12.4
configuring for Oracle InForm integration, 15.3

R

rate lists, setting up for billing, 10.6
risk assessments, performing for clinical trials, 4.14

S

Siebel Assignment Manager, using in Siebel Clinical, 3.11
Siebel Clinical
about setting up, 3.1
activating workflow policies for, 3.5
administrative setup tasks for, 3.9
configuring properties for in Siebel Tools, 3.2
configuring Web services for, 3.6
contact assignments in, 3.11.2
enabling or disabling Siebel Open UI for, 3.3
enabling Siebel Server component groups for, 3.4
integration entities for, 16.4
setting up for integration with third-party payments application, 3.8
using Siebel Assignment Manager in, 3.11
Siebel Clinical Trial Management System
about, 2.1
features of, 2.2
product modules and options for, 2.3
Siebel Open UI, enabling or disabling for Siebel Clinical, 3.3
Siebel Server component groups
enabling for Siebel Clinical, 3.4
enabling for site visit data integration, 13.3.3
Siebel Server, creating directory structure for, 16.3.5
Siebel SmartScript, creating questions for clinical trip reports using, 9.3
Siebel Tools
configuring for clinical data management system integration, 16.3.1
configuring for clinical payments integration, 17.3.1
configuring properties for Siebel Clinical in, 3.2
site enrollment status, generating Oracle BI Publisher reports for, 5.23
site teams, assigning employees to, 6.15
site visit data integration
about customizing Web services for, 13.2
activating workflows for, 13.3.1
configuring Web services for, 13.3.2
enabling Siebel Server component groups for, 13.3.3
overview of, 13.1
process of setting up, 13.3
site visits
about exporting data for, 13.4
creating and managing, 6.12
generating Oracle BI Publisher reports for, 9.20
tracking case reports forms for partial source data verification during, 7.8
viewing geographical location details for, 13.6
sites
about exporting data for, 12.6, 14.11, 15.5
about managing for clinical trials, 6.1
about synchronizing, 16.10
activating synchronization of data for, 16.8
adding address types for, 6.14
adding notes to, 6.23
adding training plans to, 11.8
adjusting payment amounts and generating payment records for, 8.13
applying activity templates to, 6.17
applying protocol amendments to, 5.15
applying revised subject visit templates to, 5.15.1
associating contracts with, 6.7
associating with accounts, 4.13, 6.9
associating with activities, 6.10
associating with documents, 6.11
changing training topics for, 11.9
creating activity plans for, 6.16
creating correspondence activities for, 6.22
creating for clinical trials, 4.12
creating payment activities for, 8.9
generating final payments for, 8.14
generating payment records for, 8.10, 8.11
managing contacts for, 6.13
process of managing for clinical trials, 6.3
scenario for managing for clinical trials, 6.2
setting up partial source data verification for, 7.5
setting up payment exceptions for, 8.4
tracking and adding documents at, 6.18
tracking status accruals for clinical subjects of, 9.12
viewing status accruals for clinical subjects of, 5.17
viewing status history for, 6.24
SmartScript metadata, about exporting for clinical trip reports, 14.16
snapshot data, about exporting for site enrollments, 14.14
source data verification, recalculating clinical subjects requiring, 7.9
standard payment amounts, setting up in subject visit templates, 8.3
state transition data, about exporting for clinical trip reports, 14.13
status accruals
monitoring for clinical subjects by visit type, 5.21
tracking for clinical subjects of sites, 9.12
viewing for clinical subjects of clinical protocols, 5.19
viewing for clinical subjects of clinical regions, 5.18
viewing for clinical subjects of sites, 5.17
status history, viewing for sites, 6.24
subject activities
about setting up and making clinical payments for, 8.1
marking as complete, 8.8
subject enrollment
about rolling up information for, 5.16
monitoring rates for, 5.20
subject status
about automatic tracking of, 5.4
overriding initial, 5.12
using audit trail for changes to, 5.22
subject visit templates
about, 5.1
applying to clinical subjects, 5.15.2
applying to sites, 5.15.1
approving, 5.3
creating, 5.2.1
defining versions for, 5.2.2
process of defining, 5.2
setting up partial source data verification for, 7.4
setting up standard payment amounts in, 8.3
subject visits
about exporting data for, 14.10
administering in batch mode, 5.7
creating unscheduled, 5.13
defining, 5.2.3
defining activities for, 5.2.5
defining planned, 5.2.4
generating reports for actual, 6.27
generating reports for planned and actual dates of, 6.28
integrating data with data for activities, 15.4, 16.7
rules for deleting when deemed non-applicable by early termination, 5.15.4
system preferences
configuring for clinical operations integration, 12.3.5
in Siebel Clinical, B.6

T

tasks, creating for clinical projects, 10.9
team assignment history, tracking and revising, 4.6
template data, about exporting for clinical trip reports, 14.15
third-party payments application
sending payment requests to, 17.4
setting up Siebel Clinical for integration with, 3.8
time format, configuring for ClearTrial integration, 12.3.4
tracking activities, managing for case report forms, 6.20
training plans
about publishing, 11.6
adding criteria to, 11.4
adding to clinical sites, 11.8
creating, 11.3
creating versions of, 11.5
publishing, 11.7
training topics
changing for clinical sites, 11.9
designating completed training for, 11.10
setting up for clinical training, 11.2

U

universal inbox notifications, viewing for action items of clinical trip reports, 9.13
user properties
for business components in Siebel Clinical, B.2
for business services in Siebel Clinical, B.3
overview of for Siebel Clinical, B.1
users
about adding to MVG for Assigned To fields, 14.8
about exporting data for Siebel Clinical, 14.7

V

versions
creating and revising for clinical protocols, 4.7
creating for training plans, 11.5
defining for subject visit templates, 5.2.2
visit type, monitoring status accruals for clinical subjects by, 5.21

W

Web services
about customizing for clinical data management system integration, 16.2
about customizing for clinical operations integration, 12.2
about customizing for clinical payments integration, 17.2
about customizing for mobile integration of clinical trip reports, 14.2
about customizing for site visit data integration, 13.2
configuring for ClearTrial integration, 12.3.3
configuring for clinical data capture and query management system integration, 15.2.3
configuring for clinical data management system integration, 16.3.4
configuring for mobile integration, 14.4.3
configuring for Siebel Clinical, 3.6
configuring for site visit data integration, 13.3.2
in Siebel Clinical, B.8
workflow policies, activating for Siebel Clinical, 3.5
workflows
activating for ClearTrial integration, 12.3.2
activating for clinical data capture and query management system integration, 15.2.1
activating for clinical data management system integration, 16.3.2
activating for clinical payments integration, 17.3.2
activating for mobile integration, 14.4.2
activating for site visit data integration, 13.3.1
for mobile integration of clinical trip reports, 14.3
in Siebel Clinical, B.7

X

XML file
exporting DTE data maps from server database to, 3.12.1.1
importing DTE data maps from local client to, 3.12.1.2
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